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A cost-based assessment of Protocol W and PANORAMA clinical data suggests diabetic retinopathy may be less costly to prevent than macular edema.
The use of intravitreal aflibercept injections for the prevention of proliferative diabetic retinopathy (PDR) is associated with a significant patient cost of care, according to new research presented at the American Academy of Ophthalmology (AAO) 2021 Meeting in New Orleans.
A team of US investigators reported data at the annual ophthalmology meeting showing that the most commonly prescribed anti-VEGF injection therapy for diabetic retinopathy is associated with a cost upwards of $80,000 to prevent a single case of PDR. The research also presented a novel parameter for PDR treatment utility analysis: a metric which incorporates the commonly-used Diabetic Retinopathy Severity Score (DRSS) with treatment cost.
Led by Nimesh A. Patel, MD, Professor of Ophthalmology at Harvard Medical School, investigators sought to define costs required to prevent PDR and reduce progression of DRSS with anti-VEGF injections. Their assessment included data from the Protocol W and PANORAMA trials, in which intravitreal aflibercept was evaluated for improvement in standard PDR efficacy outcomes including DRSS and visual acuity (VA).
“Novel metrics are needed to determine the cost-utility of preventing PDR with aflibercept in the absence of significant visual improvement,” Patel and colleagues wrote.
The investigators analyzed results from the recent clinical trials, collecting metrics including DRSS, PDR risk reduction in treated patients, risk reduction of center-involved diabetic macular edema (CI-DME), and total treatments required in care.
They additionally modeled treatment costs based on 2020 Medicare reimbursement data, and stratified by practice settings of hospital-based facility and non-facility.
Patel and colleagues observed a greater cost-benefit of intravitreal aflibercept in the first year of treatment despite patients needing more frequent injections during that time. The cost per unit of DRSS saved was $2100 in year 1, $6100 in year 2, and $3000 in total at 2 years.
In the Protocol W cohort, patients required 5.08 injections to prevent 1 case of PDR—or a cost of $72,400 over 2 years. In the PANORAMA cohort receiving 2 mg aflibercept every 16 weeks after 3 initial monthly doses and one 8-week interval (2Q16), the rate was 4.65 and cost was $75,000. For the PANORAMA cohort receiving 2 mg aflibercept every 8 weeks after 5 initial monthly doses and pro re nata dosing beginning at week 56 (2Q8 PRN), the rate was 4.22 and the cost was $89,900.
The cost to prevent a case of CI-DME in the PANORAMA cohorts were $59,500 and $88,800, respectively. The cost to prevent CI-DME plus vision loss in Protocol W patients was $133,000.
“There is a considerable cost associated with the prevention of PDR with intravitreal aflibercept injections,” investigators concluded. “The price per unit of change in DRSS is a new parameter that can serve as a benchmark in future utility analyses.”
The study, “A Cost-Effectiveness Analysis of Intravitreal Aflibercept for the Prevention of Proliferative Diabetic Retinopathy,” was presented at AAO 2021.